drugset / Trial / NCT03325465

Neoadjuvant Pembrolizumab + Epacadostat Prior to Curative Surgical Care for Squamous Cell Carcinoma of the Head and Neck

NCT03325465

Phase 2 Withdrawn University of Chicago
NaSingle-groupOpen-labelTreatment

Summary

The KEO study is a single arm phase II trial including 44 patients with T1N1-2B, T2N0-N2B head and neck squamous cell carcinoma (HNSCC) eligible for curative-intent resection (+/- adjuvant therapy), who receive neo-adjvuant pembrolizumab + epacadostat. The primary objective of this study is to determine rate of major treatment effect (MTE) to neoadjuvant pembrolizumab+epacostat immunotherapy in SCCHN compared to historic data with neoadjuvant pembrolizumab alone.

Timeline

Start
2018-01-22
Primary completion
2018-11-07
Completion
2018-11-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Epacadostat Small molecule 100 mg Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous